FDA WARNING_LETTER - Organics Corporation of America DBA Ambix Laboratories - May 07, 2012

The FDA inspected Organics Corporation of America (DBA Ambix Laboratories) in Totowa, NJ, from April 9 to May 7, 2012, and found serious violations of dietary supplement CGMP regulations (21 CFR Part 111). This renders their Baby Plex Vitamin Drops, Carnitine Liquid, and Optimal Nutritional Liquid products adulterated.

Key violations include: 1. **Failure to verify finished batch specifications (21 CFR 111.75(c)):** The firm manufactured numerous batches of the listed products since 2010 without testing to verify identity, purity, strength, composition, or contamination limits. Their proposed corrective action lacked a sound statistical plan for subset testing and did not address purity, strength, or contamination. 2. **Failure to verify component identity and specifications (21 CFR 111.75(a)(1)(i), 111.75(a)(2)):** The firm did not conduct appropriate tests to verify the identity of dietary ingredients or confirm specifications for other components in Baby Plex Vitamin Drops, Optimal Nutrition Liquid, and Carnitine Liquid. Their response lacked "current Ambix specification" documentation and supporting evidence for retesting raw materials. 3. **Failure to maintain equipment logs (21 CFR 111.35(b)(2)):** The firm did not keep records of cleaning and sanitizing equipment used